An Early View of Real-World Patient Response to Sacubitril/Valsartan: A Retrospective Study of Patients with Heart Failure with Reduced Ejection Fraction
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Sacubitril/valsartan has been established as an effective treatment for heart failure (HF) with reduced ejection fraction based on clinical trial data; however, little is known about its use or impact in real-world practice.
This study included data from medical and pharmacy claims and medical records review for patients (n = 200) who initiated sacubitril/valsartan between August 2015 and March 2016 preceding issuance of American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) focused update on new pharmacological therapy for HF (May 2016), which included recommendations for sacubitril/valsartan. A within-subject analysis compared symptoms and healthcare resource utilization before and after treatment initiation.
Patients treated with sacubitril/valsartan had multiple comorbidities, and nearly all had previous treatment for HF. Most patients initiated sacubitril/valsartan at the lowest dose of 24/26 mg twice a day (BID), which remained unchanged during the observation period for half of the patients. During the first 6 weeks of treatment, few patients discontinued sacubitril/valsartan treatment (5.5%), and only 17% achieved the target dose of 97/103 mg BID after 4 months of treatment. The proportion of patients with ≥ 1 all-cause inpatient stay decreased significantly between the pre-initiation period (27.5%) and the post-initiation period (17.0%), P = 0.009. Fatigue was noted in 51.8% of patients pre-initiation and 39.5% post-initiation, P = 0.027. Shortness of breath was documented for 66.7% of patients pre-initiation and 51.8% post-initiation, P = 0.008.
The findings of this real-world investigation suggest sacubitril/valsartan is associated with symptom improvements and a reduction in hospitalizations within 4 months of treatment for patients with HF and reduced ejection fraction.
Novartis Pharmaceuticals Corporation.
KeywordsCardiology Dyspnea Ejection fraction Fatigue Heart failure Hospitalization Sacubitril/valsartan
We thank the participants of this study.
This work, including journal processing fees, was supported by Novartis Pharmaceuticals Corporation located in East Hanover, New Jersey, USA. Employees of Novartis participated in the study design, research, manuscript creation, and decision to publish in collaboration with Comprehensive Health Insights employees. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published.
We thank Mary Costantino, PhD and Neelam Davis, PharmD, both employees of Comprehensive Health Insights, for their editorial assistance in preparing this manuscript and George Andrews, MD for his review of the manuscript. Editorial assistance was funded by Novartis Pharmaceuticals Corporation.
This research was conducted collaboratively between Novartis Pharmaceuticals Corporation and Comprehensive Health Insights, a subsidiary of Humana Inc. Dana Drzayich Antol is an employee of Comprehensive Health Insights, Inc. and owns stock in Humana Inc. Adrianne Waldman Casebeer is an employee of Comprehensive Health Insights, Inc. and owns stock in Humana Inc. Richard W. DeClue is an employee of Comprehensive Health Insights, Inc. Stephen Stemkowski is an employee of Comprehensive Health Insights, Inc and owns stock in Humana Inc. Patricia A. Russo is an employee of Novartis Pharmaceuticals Corporation and owns stock in Novartis AG.
Compliance with Ethics Guidelines
Prior to initiation of this study, approval was obtained from Schulman Associates institutional review board. This study conformed to the Helsinki Declaration of 1964, as revised in 2013, concerning human and animal rights, and Springer’s policy concerning informed consent has been followed. This article does not contain any new studies with human or animal subjects performed by any of the authors.
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